Director CMC Statistics

Job not on LinkedIn

October 29

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $207k - $238.6k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

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Amgen

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Biotechnology • Pharmaceuticals • Science

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

📋 Description

• Serve as Amgen’s leader in advanced statistical modeling for CMC development and commercial support • Drive innovation in kinetic modeling, Bayesian statistics, and predictive methods to accelerate decision-making across Amgen’s product portfolio • Ensure best-in-class application of advanced modeling techniques to CMC data, spanning drug substance, drug product, and delivery device development • Provide strategic and technical leadership in the design and implementation of kinetic modeling, Bayesian methods, and predictive analytics to support product and process characterization, stability modeling, and specification setting • Lead development and application of statistical/mathematical models to optimize manufacturing processes, evaluate product lifecycle and stability data, and support regulatory submissions • Champion the integration of Bayesian methods and modeling frameworks to enhance data utilization, manage uncertainty, and improve decision-making across the CMC lifecycle • Partner with cross-functional teams (Process Development, Analytical Sciences, Quality, Manufacturing, and Regulatory) to ensure modeling strategies are aligned with Amgen’s business and scientific objectives • Contribute to regulatory strategies by developing and defending modeling-based justifications in submissions and at regulatory authority interactions • Advance Amgen’s digital and data science strategy by incorporating machine learning, simulation, AI, and automation approaches into statistical workflows • Represent Amgen externally through scientific collaborations, publications, and conference presentations to establish thought leadership in CMC modeling • Train & guide other statisticians & data scientists in the use of innovative statistical approaches, including but not limited to kinetic, Bayesian, and predictive modeling

🎯 Requirements

• Doctorate degree and 4 years of relevant biopharmaceutical industry experience OR Master’s degree and 8 years of relevant biopharmaceutical industry experience OR Bachelor's degree and 10 years of relevant biopharmaceutical industry experience • At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources • Degree in Statistics, Biostatistics, Applied Mathematics, Engineering, or related quantitative field • Deep expertise in kinetic modeling, Bayesian methods, and advanced statistical modeling techniques • Strong track record of applying statistical modeling to CMC data, including stability, comparability, process characterization, and analytical method development • Proficiency with statistical software (e.g., R, SAS, JMP, Minitab) and modeling tools (e.g., NONMEM, MATLAB, Stan, or similar Bayesian frameworks) • Demonstrated success influencing regulatory strategies through modeling-based approaches • Proven ability to lead and develop technical talent in statistics and modeling • Excellent oral and written communication skills, with ability to explain complex modeling approaches to both technical and non-technical audiences • Experience working in cross-functional and global team environments.

🏖️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and vision coverage • life and disability insurance • flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements, where possible